"""LnK Posterior Cervical Fixation System/ CastleLoc-S Posterior Cervical Fixation"

Primary DI
08809986477682
Brand
"""LnK Posterior Cervical Fixation System/ CastleLoc-S Posterior Cervical Fixation"
Company
L&K BIOMED CO. ,LTD.
Model
6112-5530
Device description
Semi Poly Screw 5.5X30mm
Published
2025-04-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NKGPosterior Cervical Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200793000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200793000LnK Posterior Cervical Fixation System and CastleLoc-S Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.2020-10-08NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809986477682PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809986477682088099864776828809986477682

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
631159324
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809986492791CastleLoc-P Anterior Cervical Plate System6610-4020S2026-06-09
08809986492807CastleLoc-P Anterior Cervical Plate System6610-4021S2026-06-09
08809986492814CastleLoc-P Anterior Cervical Plate System6610-4022S2026-06-09
08809986479938CastleLoc Pectus Bar SystemPB28-31602026-06-08
08809986479945CastleLoc Pectus Bar SystemPB28-21602026-06-08
08809986491404CastleLoc-P Anterior Cervical Plate System6913-17602026-06-08
08809986491411CastleLoc-P Anterior Cervical Plate System6913-17632026-06-08
08809986491428CastleLoc-P Anterior Cervical Plate System6913-17662026-06-08
08809986491435CastleLoc-P Anterior Cervical Plate System6913-17692026-06-08
08809986491442CastleLoc-P Anterior Cervical Plate System6913-17722026-06-08
08809986491459CastleLoc-P Anterior Cervical Plate System6914-17652026-06-08
08809986491466CastleLoc-P Anterior Cervical Plate System6914-17692026-06-08
08809986491473CastleLoc-P Anterior Cervical Plate System6914-17732026-06-08
08809986491480CastleLoc-P Anterior Cervical Plate System6914-17772026-06-08
08809986491497CastleLoc-P Anterior Cervical Plate System6914-17812026-06-08
08809986491503CastleLoc-P Anterior Cervical Plate System6914-17852026-06-08
08809986491510CastleLoc-P Anterior Cervical Plate System6914-17892026-06-08
08809986491527CastleLoc-P Anterior Cervical Plate System6914-17932026-06-08
08809986491534CastleLoc-P Anterior Cervical Plate System6914-17972026-06-08
08809986491541CastleLoc-P Anterior Cervical Plate System6609-35122026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536163403neon3Ulrich GmbH & Co. KGNKG2026-06-09
04052536163410neon3Ulrich GmbH & Co. KGNKG2026-06-09
04052536162109neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGNKG2026-06-08
00840283403897VySpan™VY SPINE LLCNKG2026-06-05
00840283403927VySpan™VY SPINE LLCNKG2026-06-05
04052536085491neon3Ulrich GmbH & Co. KGNKG2026-05-28
07630345705860M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705877M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705884M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705891M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705907M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705914M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705921M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705938M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705945M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630345705952M.U.S.T. MINI Rod To Rod ConnectorMedacta International SANKG2020-11-30
07630971299559M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299566M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-30
07630971299528M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299535M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299542M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-25
07630971299368M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19
07630971299375M.U.S.T. MINI Anodized RodMedacta International SANKG2020-11-19